Are DAISOGEL Products Registered in FDA DMF?

According to the US FDA, “drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.” 

There are several types of DMFs. Type II DMFs are applied to  “Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product.” 

The top-selling DAISOGEL phases have Type II FDA DMF registration. Our rigid manufacturing standards guarantee that only the highest quality silica gel products are delivered to our valued customers. We have FDA DMF registration for the following phases:

We also have Regulatory Support Files for the same products available upon request.

Contact us to learn more

Reach out to us for regulatory support of the DAISOGEL phase used in your registered production process.

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